Autologous Tumour Vaccine Trial

NCT ID: NCT05807035

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2028-02-10

Brief Summary

Phase 1 trial to evaluate the feasibility of preparation, safety, tolerability and response to a personalised autologous tumour vaccine (ATV) formulated with Advax adjuvant when administered to patients with advanced solid cancers either as monotherapy or in combination with other standard of care agents

Detailed Description

Radvax is a newly developed vaccine where extracted autologous tumour proteins are combined with the non-inflammatory Advax delta inulin adjuvant. Cancer immunotherapy has had a renewed interest due to the recent success and regulatory approval of immune checkpoint inhibitors and CAR-T cells. However, only a proportion of cancer patients derive benefit from these agents and hence there is an ongoing need to improve outcomes of patients with advanced solid tumours. Radvax is a novel simplified ATV approach whereby soluble tumour antigens are extracted from tumour samples obtained at surgery or from biopsy and formulated with Advax adjuvant. This vaccine has shown efficacy in murine models of glioma and pancreatic cancer, clinical trials of canine cancer patients. Radvax is now being assessed in a Phase 1 clinical trial of advanced solid cancers. Autologous tumour vaccines (ATV) will be generated from surgically removed or biopsied fresh tumour tissue. ATV is manufactured as a tumour lysate extract which is stored frozen, and then formulated with Advax adjuvant on day of administration. Doses of ATV will be administered on days 1, 8, 15, 22 during cycle 1 and then 4 weeks thereafter until total of up to 12 cycles Primary Endpoint(s): Incidence of grade 3 or 4 adverse effects Secondary Endpoint(s): Response rates by iRECIST, progression free survival and overall survival Exploratory Endpoints: To study parameters and predictive biomarkers of cancer response

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radvax

This is a single arm study where all participants will get active Radvax autologous tumour vaccine weekly for 4 weeks and then monthly thereafter

Group Type: EXPERIMENTAL

Radvax

Intervention Type: BIOLOGICAL

Vaccine extracted from patient's own tumour tissue formulated with polysaccharide adjuvant

Interventions

Radvax

Vaccine extracted from patient's own tumour tissue formulated with polysaccharide adjuvant

Intervention Type: BIOLOGICAL

Other Intervention Names

Autologous tumor vaccine

Eligibility Criteria

Inclusion Criteria

• Subjects must have histologically or cytologically confirmed advanced solid cancers or hematological cancers (lymphomas only)
• Subjects must have received at least one prior therapy for this disease, with the exception that subjects for whom no standard therapy options exist or who decline standard therapies can be considered for inclusion after discussions with the investigator team.
• Performance status ≤ 2 (ECOG performance status)
• Subjects or their parents if a child must have the ability to understand and the willingness to sign a written informed consent document.
• If no suitable cancer tissue is already available to make the vaccine, to be enrolled in the trial participants must be willing to undergo surgery and/or fresh tumour biopsy to obtain tissue to allow the preparation of the vaccine and their primary care team needs to have agreed to perform these procedures for them to obtain tumour tissue. The trial team will provide advice on appropriate tissue collection and arrange transport and processing but are not responsible for arranging such surgery or paying for its cost.

Exclusion Criteria

• Subjects receiving any other investigational agents within the preceding 4 weeks.
• Pregnant women because of the unknown risk of adverse events in the foetus secondary to treatment of the mother with ATV.
• Any potential participant where suitable cancer tissue is not available for preparation of the vaccine
• Any condition that the Investigator deems may make a potential participant unsuitable for entry into the trial.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Australian Respiratory and Sleep Medicine Institute

OTHER

Sponsor Role: collaborator

Vaxine Pty Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dimitar Sajkov, MBBS/PhD

Role: PRINCIPAL_INVESTIGATOR

ARASMI

Locations

ARASMI

Adelaide, South Australia, Australia

Site Status: RECRUITING

Countries

Australia

Central Contacts

Sharen Pringle, GradCert

Role: CONTACT

office@arasmi.org

0437033400

Facility Contacts

Sharen Pringle

Role: primary

office@arasmi.org

0437033400

Other Identifiers

CAN001

Identifier Type: -

Identifier Source: org_study_id